Proposal: Create a Comprehensive Treatment Review Program

This thread contains background information and my ideas about this project. I'm trying to gauge interest and get suggestions.

(The topics embedded in this page are being split into different threads for discussion.)

Background - I first thought of creating a comprehensive treatment assessment program on the Phoenix Rising website about a year and a half ago.

My ideas about the project have grown over time (quite a bit :Retro redface. It would have several purposes/possibilities.

to come up with a way for patients to easily find treatments that are more likely to work for her/him by giving them the capability to identify similar patients to them and learning what is not working and what is working for them

to gather useful information on treatment options that could be transmitted to drug companies, doctors, etc. that will help them refine their treatment approach to ME/CFS; this is apparently what PatientsLikeME is doing.

Tease out different types of ME/CFS patients and compare them using a variety of factors (ie onset, duration, test results, treatment effectiveness, etc. ie - attempt to find the subsets

Provide a comprehensive profile of the ME/CFS Community

To that end I've spent a great deal of time over the past year and a half trying to learn computer programming. It’s become clear to me that it would take me a great deal of time to get up to snuff enough to produce this kind of program. With some dollars adding up from donations I embarked a couple of months ago on an exploration of how expensive it would be to create such a site. At one point I learned a similar program had already been created.

PatientsLikeMe- I learned about the PatientsLikeME site about nine months ago. PatientsLikeMe is very innovative, forward thinking treatment review site that has the nice benefit of apparently being run by very good people.

PLM allows patients FM patients, for instance, quickly how effective a drug, say lyrica, is at reducing pain in the FM community at large. It allows them to see what side effects patients generally experience, what dosages work the best. You can punch in a symptom - say migraine - and get a list of treatments used to battle that. Click on a treatment and you get the information I mentioned above - what people use it for and how effective it is. Then you can click on a patient who's using it and see what their comments on it are and what side effects, etc they personally experienced. Finally you can follow that patient over time and see how they do on the drug.

The site is clearly a huge step up in the treatment review field and will, I would think, redefine how treatments are assessed in the medical field, vastly increase the medical community's understanding of which types of treatments are effective for which types of patients and basically be a huge boost for patients everywhere. It’s a great site! One way or another the CFS community should take advantage of this type of site.

PatientsLikeMe added chronic fatigue syndrome to its Fibromyalgia section in the past year. They are subsumed within a sea of FM patients and in a section that was built specifically for fibromyalgia. While the initial symptom base doesn't look all that much like CFS it is possible for CFS patients to make it more CFS-like by adding symptoms to the list. Still, to some extent, CFS patients are bit of a round peg trying to fit into a square hole. There’s no denying, though, that this site has immense possibilities why for CFS patients as it is now.

Building a PatientsLikeMe (Plus) Site Of Our Own ​

There are good reasons to stick with PatientsLikeMe - it’s an excellent site that provides many opportunities, the owners appear to be adding capability fairly frequently, they have substantial financial backing, etc….and they may be able to do some things that would be difficult for us to do .

Doing What They Do Differently - After looking at PatientsLikeMe - there is also the opportunity to take what works and what doesn't work as well and improve on it. My conception of the site goes well beyond what PLM is trying to in several areas.

Add Test Results - Adding tests results (for those people willing to list them) is a particularly potent need in chronic fatigue syndrome because, unlike some of the diseases on that site, so many people have different test results. Imagine scanning a program for people with the same test results that you have and seeing what treatments are working for them.

Image being able to bring up a type of test result (failure on a tilt table test) and then describing the types of patient that display this. How are they different from other patients? Do they have a typical pattern of other abnormal test results? treatments work for them?

the query would go something like this= gather all patients with positive tilt test results then create a list in descending order of frequency - of test abnormalities, typical symptoms, type of onset, gender, duration of illness, activity levels, treatment effectiveness…….

Then do the same with the community at large- show a typical CFS patient right next to them.

(Yes, there are security issues with test results but we could hide individual information test result information and present test result information as an aggregate; ie people with X set of test results tried these treatments and achieved this success or failure with them -).

CFS Itself Needs to Be Characterized Better/Subsets need to be revealed - PLM does not attempt to characterize some important community variables or to pluck out Subsets - CFS, as we all know is a very complex disorder, possibly with many subsets. Creating a site specifically attuned to CFS could help us better understand that aspect of it.

PLM asks what kinds of treatment work for people with fatigue in CFS. We would ask that as well but we could also characterize ME/CFS as well: We could ask simple questions such as if type of onset effects the disease progression at all? How about Illness duration? How are people who’ve had this disease 5 years different from people who’ve had it 20 years. Dr. Maes says rates of IBS increase - do they? I’ll bet rates of MCS and FM increase. Do they? All these questions are answerable if you have a good enough database.

Examples - Gender - a very simple example, create a table or pictorial representation examining the effects of gender: males vs female on various factors . (Unfortunately I can't drop my table on here. Imagine it as a table.

Digging Deeper - This is just the beginning of how it's possible to characterize this community. For example when we query all people with HHV6 Infection - we get a page that contains pie charts or other visual aids of.....

%acute/gradual onset, average activity level, illness duration, %male/female and charts indicating most common symptoms, most common other positive test results, treatments tried, -----to be determined

Then we compare them to the ‘typical’ CFS patient - same variables aggregated over the entire community - an easy to understand picture of this type of patient and how they differ from others

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Characterize the ME/CFS Community while we’re at it- why not go whole hog and provide a snapshot of the ME/CFS Community while we’re at it. Much of the information we gather is not available.

• Work status (part-time, full time, not working)
• Date last worked for pay (average)
• Education Level
• Disability/Social Services utilized (% using government disability, private disability, other government support???)
• Finances - % government disability /private disability support/family support/no outside support
• My health over the past year has…improved, gotten worse, etc.
• Since I came down with CFS my health has……..
• Common co-occurring diagnoses

Medical community satisfaction

• Type of physician/physicians seen
• Satisfaction with current physician
• health practitioner level of expertise in ME/CFS
• I am not seeing a physician because (finances prevent, no suitable physicians available, tired of wasting my money))

The Phoenix Rising Forums - we would also be able to integrate the Forum package, with all its capabilities, into the site.

Physicians - We could also include a Physician variable which allow patients to access patients by Physician - thus allowing patients to examine how a broad swath of patients under Dr. Cheney’s, Dr. Peterson’s, etc care are doing.

I’m basically committed to doing this project. Jerry (xlynx), a forum member and software developer, has agreed to oversee it on the technical end. He believes it would not be difficult to meet PatientsLikeMe’s capabilities and encourages us to find ways to surpass PatientsLikeMe (PLM) in its application in CFS. In short he thinks we should ‘think big’.

Costs:

I’ve presented a First Stage of the site like PLM to several programmers based in India, one in the US and to Jerry. Stage I would include virtually everything you see on the PatientsLikeMe Site minus the ability to track treatments over time (Stage II) and not including my potential additions. These were preliminary forays to get a sense of how much something like this would cost.

The bids to create a site like this, thus far, have ranged from 5-6k (India), 6-10k (US) and we’re waiting on another bid from India. Jerry believes a single programmer working for three or four months at somewhere around $1800 a month could produce this site. I rather suspect they are on the low end. I can kick it off with perhaps a quarter of the total needed for the low-end estimate.

1) Measurement tool for assessing functionality/quality of life: Bell's scale is specifc to CFS/ME but the SF-36 is utilized extensively. Here is a link to check it out: http://www.sf-36.org/tools/sf36.shtml. I had brought that up to PLM awhile ago and it was a condideration since it is a tool that can be used across conditions. It would also enable those without knowledge of Bell's scale to see the level of function or dysfunction many have.

2) Start a spreadsheet (excel) listing all the tests commonly being performed for patients. We would need to include the test name, units of measure for results, methodology (e.g. PCR, culture, serology), and where performed. As I mentioned to you previously, tests vary depending upon where they are performed. A simplified approach would be positive or negative for tests like XMRV, EBV, HHV-6, etc. They could be positive/negative regardless of type of test. Spreadsheets can be uploaded into access databases...I'm 99% sure. Jerry probably knows this already.

3) Any database would need to be relational with search/reporting capabilities like Access or SQL. Reports can be dumped into excel for statistical analysis unless other programs are available.

4) Funding.....I think there are opportunities here!

When I have more ideas, I'll let you know! Hopefully, many will jump on this!

My gut reaction is it's too ambitious to try right off the bat. A better way would be to select one or more modules that have the most immediate relevance and to them as pilot projects. But before doing that, see if anyone else is doing them. And if they are, see if we can share data. Also, (and I wish I could find the link) CFS Experimental has system for evaluating the success of variuos treatments based on member reports. Maybe that would be a good systim to use.

Thanks Andrew. It certainly is an ambitious project. I think we would probably try to do this in stages; create the basic framework (treatment reviews/community section) and then add to it as it is feasible.

Aside from PatientsLikeMe I don't know of anyone else who is doing anything like this but if you can find some functionality out there in CFS Community we could tap into please let me know.

1) Measurement tool for assessing functionality/quality of life: Bell's scale is specifc to CFS/ME but the SF-36 is utilized extensively. Here is a link to check it out: http://www.sf-36.org/tools/sf36.shtml. I had brought that up to PLM awhile ago and it was a condideration since it is a tool that can be used across conditions. It would also enable those without knowledge of Bell's scale to see the level of function or dysfunction many have.

2) Start a spreadsheet (excel) listing all the tests commonly being performed for patients. We would need to include the test name, units of measure for results, methodology (e.g. PCR, culture, serology), and where performed. As I mentioned to you previously, tests vary depending upon where they are performed. A simplified approach would be positive or negative for tests like XMRV, EBV, HHV-6, etc. They could be positive/negative regardless of type of test. Spreadsheets can be uploaded into access databases...I'm 99% sure. Jerry probably knows this already.

3) Any database would need to be relational with search/reporting capabilities like Access or SQL. Reports can be dumped into excel for statistical analysis unless other programs are available.

4) Funding.....I think there are opportunities here!

When I have more ideas, I'll let you know! Hopefully, many will jump on this!

~ JT

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Thanks JT - good idea of on the SF-36; from my knowledge that is the most commonly used test in the research field.

Gathering the tests together will be interesting given all the different types of tests; I think its a good idea to have a simple measure available (postive for HHV-6, positive for low cortisol, etc). that would allow people to easily find other 'patientslikethem' .

Thanks for the ideas. I think something like this, done right, could redefine how many people look at CFS. We know we get alot of traffic of all sorts here. I think it could be valuable not only for identifying subsets and helping people to find good treatments (and avoid spending money on bad ones) but I can see something like this enlarging ours and others knowledge of ME/CFS dramatically.

What I've thought we've needed is a huge study with lots of people, lots of laboratory measurements and symptoms etc - that will allow the different subsets to appear. This is like that - think of it a database of 1000 patients that you can query.....it would be an amazing tool for learning.

Here's another example of the list of treatments that are helping some PWCs ... FWIW. Based on the lists provided at Patientslikeme and DailyStrength, one could just as easily take any page out of the PDR or holistic guide book and get the same information.

Hopefully, you/we could come up with something that actually gives PWCs some guidance and doesn't just confuse the issue further. IMHO, Dr. Myhill has already come a long way in providing the info we need to heal ...

Taking a close look at Dr. MyHills treatments should give them a real boost if they're working. Just imagine if people could quickly and easily see a bunch of people improving on a couple of treatments. No need to find them and question them - its all right there in black and while (or rather in colors in this case). This would be a way to spread the word fast.

good idea Cort.i dont think that subsets exist.It can be a useful metaphor but CFS doesn't really exist in any mind independent sense but is a politically motivated label.As there is no objective relationship between the label and the illness the label itself will create subsets as an artefact.There may well be different symptomatic presentations but central unifying causation.If this is not so then CFS is merely an umbrella term for entirely seperate conditions having the symptom of fatigue in common. A physical disability scale on its own is far to blunt an instrument fot many neurocognitive disability is more of a problem.With some it is both.If there are different categories they would be more accurately represented by symptoms in a number of neuroimmunoendocrine dimensions

good idea Cort.i dont think that subsets exist.It can be a useful metaphor but CFS doesn't really exist in any mind independent sense but is a politically motivated label.As there is no objective relationship between the label and the illness the label itself will create subsets as an artefact.There may well be different symptomatic presentations but central unifying causation.If this is not so then CFS is merely an umbrella term for entirely seperate conditions having the symptom of fatigue in common. A physical disability scale on its own is far to blunt an instrument fot many neurocognitive disability is more of a problem.With some it is both.If there are different categories they would be more accurately represented by symptoms in a number of neuroimmunoendocrine dimensions

Cheers Gerwyn

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Thanks Gerwyn. What you say may very well be true; in fact when you look at different types of symptom presentations its hard to escape the idea that the CFS label encapsulates different diseases. My hope is that this kind of program - by building up a large database with lots of patients with lots of data will be able to tease these different groups out.

My preliminary idea has been to create something like this

• Symptom Chart: A pictoral (graph/chart) assessment of the patients symptoms - probably dividing them into categories (immune, nervous, endocrine associated - using the Canadian Consensus Criteria categories) and creating a representation of what kinds of symptoms are most prevalent

• Test Result Chart: A pictoral (piechart) assessment of the test results - probably dividing them into categories (immune, nervous, endocrine associated) and creating a representation of what kinds of positive test results are most prevalent in the CFS population
this is just an idea and should better ways
These little piecharts would go across the project: on each individual profile page you get a pie chart showing their symptom presentation (piechart broken up into categories of symptoms.) You can immediately see, if this is done right, if they have more a 'immunish' or have more neurological, gut etc. whatever symptom presentation. Right next to that piechart you have a piechart that represents the CFS community at large.

I haven't looked into the categories on the CCC but as I remember the list of symptoms is pretty extensive. We'd have to figure out a way an algorythm to give more significant symptoms more weight.

You could do this across the website: under each treatment or test result - you could list the typical symptom presentation of everyone who used that treatment.

This is just a preliminary idea I had, I'm sure there are better ways to do it.

Good idea on the neurocognitive issue - I wonder if there's a simple test or questionnaire we could include that would measure that.

Thanks for the new abbreviation (OTOH). I just found out that LOL meant laughing out loud - after years of believing it meant 'lots of luck'

Also, involving WPI and VIPDxmay help. VIPDx most likely has a lab computer system. ARUP is another option as they will definitely have a computer system. Whether the system has the capability to extract tests based on diagnosis codes (ICD-9-CM) is a big issue. Also ARUP may not be able or willing to provide such data even if it is "scrubbed" of an identifying information.

With patients spread out all over the world, various countries will have differences in classifying patients. In the US, ICD9 is still in effect and will be until October 1, 2013. As far as what countries have implemented ICD-10-CM, I'm not sure. Also, where patients are denied benefits or treated negligently based on the dx of ME/CFS, their records may not even document such a diagnosis.

Given the huge issues of privacy, obtaining data from patients directly so their results are more blinded might be the way to go. That would be beneficial since patients themselves would become aware of their own data if they have not been to this point.

Data integrity is a huge issue. Bad data can ruin analytical efforts (GIGO). PLM appears to be on top of the data integrity issues.

1. Even if all info about pwME on this site, when prepared for statistical analysis, is properly anonymized e.g. by replacing their names by a number, it is likely that one who would want to and is savvy in the relevant ways, may link up the symptoms of patient nr N on the statistical survey with the stories of the patient who calls him or herself Y on the forums, in some cases at least.

It is also difficult to make this impossible, but then the reason would be that Y did say rather a lot about Y on the forums and filled out the statistics for Y (that anonymized ended up as patient nr N) conforming to Y's utterances on the forums.

2. In general, I don't believe the internet is safe - and I am computersavvy.

This being said, I also think the PR forums offer a hitherto not existing chance to gather and analyse data from a lot of pwME, and I do think it should happen.

If you were to ask why (I think not, but anyway):

E.g. because: The group is huge, compared to standard groups used in so-called scientific research; it's highly probable that the vast majority of the members do satisfy the Canada criterions; their is a wide spreading in the group geographically and as regards health-problems (who suffers from which symptoms in which intensities); while good statistical analyses of the data one may get, e.g. by a good questionnaire, that also involves measures to assure anonymity coupled to exhaustiveness of data, is easy with modern computers.

But as I said, privacy-issues ARE important here, especially for pwME in England, the US and Holland (where being known to "the authorities" - e.g. of the dole - as such-and-such on the PR forums may create major problems for one) and therefore should be carefully considered.

OTOH: I would not be amazed if analysing the data - when properly assembled - of the pwME at PR may help clarify or answer several problems around ME/CFS, at least, and I myself would be quite excited, qua scientific and logical psychologist, to have such data to analyse.

Indeed, my guess is that Real Scientific Researchers would be interested too and personally - if they exist and are bona fides i.e. not associated with KCL or CDC etc. - I'd prefer leaving the more intricate statistical analyses, such a ANOVAs (analyses of variance i.e. essentially what - group of - symptoms correlates with which - group of - symptoms) to them (essentially because (i) this is tricky business that (ii) requires good statistical programs that (iii) the academic pros have anyway).

Best wishes,

Maarten.

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The privacy issue is something that needs to be delved into more completely.

As far as I can figure it out - just thinking about it about it off the top of my head -within the context of this database exists - exists primarily when there is only a little data on a specific test. Say you enter a test result on cortisol. That data is never indicated on your profile - it goes straight into the database - where your file is representated by a number. When program analyses the data it's analyzing cortisol for say slot #56 - not for you.

So how could that data get linked to you? I can see that happening if there only one person with low cortisol levels. We've already said you can't be directly linked to the cortisol report - its not on your profile (and hopefully you're using a pseudonym as well). But we do have an analysis showing the symptom presentation of all people with low cortisol levels. If there was only one person who reported that result then someone could concievably plough through all the people in the program searching for that one person with that particular symptom profile.

But what if there are two or three or five people? Then the symptom profile gets changed more and more eventually making it it harder and harder impossible to match it up with a person. That's my laymen's understanding!

I would think - but don't know - you could further reduce to very low levels the problem of 'definitive identification' by not posting personal information in your profile, by not leaving your email address there, by using a tag instead of your real name, by not posting your location, address, etc.....I don't really know alot about this but I would be curious to find out how, short of hacking into a computer system, anyone who does not leave this information behind gets definitively identified - that if you leave that kind of nebulous information behind how you could get traced back to being Jane Doe, living at 2654 W. Brookshire St, London

Or if that can happen by internet use - how to avoid that? This is an important issue for us as a community and for this project, in particular, to take on. Maartens knows much more about searching the internet than I. It would be very instructive to find out how 'Not to leave a trail on the Internet' that can be traced back to you and post it here.

Different Levels of comfort - I would point that many people will have different levels of privacy that they feel they need and that websites like PatientsLikeMe or even the forums cannot function in a climate of real fear. Tens of thousands of people over there are, after all, posting intimate details about what drugs they're taking, the effects they're having and what diseases they've been diagnosed with. Simply being diagnosed with a disease, in general, of course, confers something about test results (and people are posting about their XMRV results as well). Most are using different tagnames but many also have their email addresses and photo's posted. To some extent it depends on how much privacy you need with the understanding that complete privacy obviously means - no communication either. For some people its such a worrisome issue that thats the correct option. For others its not such an issue.

Providing a Comfort Level - For us we would want to provide enough of a comfort level that many people would feel comfortable engaging in the project. That will require figuring out exactly what the privacy issues are, informing the community in a transparent manner about them and determining how we can prudently deal with them. That will obviously be a key aspect of this project as it moves forward and it will be resolved.

Any database would need to be relational with search/reporting capabilities like Access or SQL. Reports can be dumped into excel for statistical analysis unless other programs are available.

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This is an exciting idea. JT said it very well. From a practical perspective, put the data entry forms out there for each individual to complete, thus creating your huge database. Excel itself can be converted into a database, or like JT said, use Access. I've been out of the workforce for 10 years, but with every software conversion I did, the new software made use of fields (data) and culling reports from that database in any manner one chooses with percentages, too. So easy. So wonderful for reporting uses. I daresay this could be done on one's laptop with sophisticated database software. Remember the very old d-base? Showing my age now.

The type of data you want to include in the fields is, of course, the most important part of the project because that will determine your reporting output. Objectives must carefully be considered. A hundred fields to fill in could be daunting to the more severe. Also, limiting the sample size might be considered.

I know this is being done now in doctor's offices for CFS. Patient notes and test results are carefully read then input to a database. Percentages are created say on the effectiveness of trazadone as a sleep aid. The side effects are evaluated and percentages are derived say for next morning hangover.

I have 16 years experience with Excel and plenty of experience with databases and creating reports. I work for free to the extent my cognitive dysfuntion will allow which is not much.

OTOH: I would not be amazed if analysing the data - when properly assembled - of the pwME at PR may help clarify or answer several problems around ME/CFS, at least, and I myself would be quite excited, qua scientific and logical psychologist, to have such data to analyse.

Indeed, my guess is that Real Scientific Researchers would be interested too and personally - if they exist and are bona fides i.e. not associated with KCL or CDC etc. - I'd prefer leaving the more intricate statistical analyses, such a ANOVAs (analyses of variance i.e. essentially what - group of - symptoms correlates with which - group of - symptoms) to them (essentially because (i) this is tricky business that (ii) requires good statistical programs that (iii) the academic pros have anyway).

Best wishes,

Maarten.

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Thanks Maarten, I agree that the potential of this - with its potentially enormous database - to shed light on what ME/CFS really is is enormous and that researchers could be very interested in this. Once the the initial stages of the project are fleshed out more I planned to go to researchers and physicians and lay it out for them and get their opinions on it and advice on the statistical and data gathering issues.

I forgot to say: I know at least two really good statisticians who know I have ME (and know me personally fairly well since one or two decades) and will ask them whether they could help, but I have to e-mail them first etc.

They are academic pros, yea professors even .

I will report on the forums when I have replies (which may take some time).

Best wishes to all,

Maarten

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Thanks Maarten (I think I'm getting your name down ). Their assistance, if it can be gotten, would be invaluable. Getting technical assistance on this project from people within the community and contacts outside the community, is, of course, one of the big reasons for posting the project here. It's a big, big project but if done right I think it could illuminate ME/CFS tremendously for everyone.

Just imagine a database that grows and grows over time. After a couple of years you'd have 1,000's of patients in there - you'd really know what this community looks like; how ill it is, what types of patients progress, who stays stubbornly ill, what kind of treatments work, what kind of tests really matter to the patient (eg is it really important to raise cortisol levels or not?).

Creating good strong databases and data mining them has become a key part of medicine and research. That's why the CAA is creating their biobank and database. If you have the right kind of data in there you can pull out gems. If we could create a good enough database researchers would want to search it. We would never have the rigor of a scientific study but neither does PatientsLikeMe - instead we have much more real-time data - data that can be used to examine treatment outcomes, treatment efficacy and characterize the CFS community in a way that's never even been contemplated before. The idea gets me going!

Wow, the ideas are flooding in but I don't have the energy to write clearly now so I'll write a few short notes for now.

We should try to use good ideas such as Dr. Jason's sympton severity rating rather than just "do you have the symptom?". Perhaps there's a paper here. PR, et al has a nice ring... :Retro smile:

A couple of thought on the approach to building the capability. Have you talked to PLM about the cost to add desired features for a price or even getting a single non-profit "open source" copy of the PLM capability to modify as you wish? Perhaps a couple of way to stretch the $s.

You may have mentioned this, the fog hath dececded...Having this data could possibly help research. Users could opt in to being contacted by researchers. It could be blind so that email addresses are not sent to the researchers until a user responds directly to the research inquiry with interest.

It's definitly easy to overwhelm patients with questions. One possible approach would be to have the ability to quit and come back to the info entry step. Another would would be to have basic and detailed levels of information depending on user desire/ability to share more detailed info.

Thanks Otis - glad the fog lifted long enough for the ideas to get out (I hope its not as dense as the fogs I used to experience in the SF Bay area.) I'll your suggestions down - I'm creating some pages to do that.